Description:
This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
adult patients with histologically confirmed GBM and/or other glioma subtypes with
FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.
Title
- Brief Title: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
- Official Title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
Clinical Trial IDs
- ORG STUDY ID:
CBGJ398X2201
- NCT ID:
NCT01975701
Conditions
- Recurrent Glioblastoma or Other Glioma Subtypes
Interventions
Drug | Synonyms | Arms |
---|
BGJ398 | | BGJ398X |
Purpose
This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
adult patients with histologically confirmed GBM and/or other glioma subtypes with
FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.
Detailed Description
Patients were enrolled in two groups. Group 1 enrolled patients who are not candidates for
surgery. Group 2 was planned to enroll patients who are surgical candidates. Patients from
both groups were evaluated for tumor response and progression by MRI every 8 weeks until
disease progression or discontinuation from study using RANO criteria.
Trial Arms
Name | Type | Description | Interventions |
---|
BGJ398X | Experimental | To estimate anti-tumor efficacy of BGJ398 | |
Eligibility Criteria
Inclusion criteria:
1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of
diagnosis or prior relapse.
2. Written documentation of local or central laboratory determination of amplification or
translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1,
FGFR2,or FGFR3
3. RANO defined tumor progression by MRI in comparison to a prior scan
4. Patients must have received prior external beam radiotherapy and temozolomide.
Exclusion criteria:
1. History of another primary malignancy
2. Prior or current treatment with a FGFR inhibitor
3. Neurological symptoms related to underlying disease requiring increasing doses of
corticosteroids
4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously
on an EIAED, the patient must be off of it for at least two weeks prior to study
treatment.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | 6 months |
Safety Issue: | |
Description: | To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator) |
Secondary Outcome Measures
Measure: | Overall Response Rate |
Time Frame: | 5 years |
Safety Issue: | |
Description: | To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator |
Measure: | Overall Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival |
Measure: | Safety and Tolerability |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- BGJ398,
- recurrent glioblastoma'
- recurrent GBM,
- FGFR,
Last Updated
December 4, 2019